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This document is an application form for registering a new drug for local manufacture and sale in Pakistan. It requests information about the drug such as its name, manufacturer, composition, dosage, clinical use, side effects, stability studies, packaging, and pricing. The applicant is required to provide details on the drug's manufacture and quality control processes as well as proposed labeling. Additional information must be submitted for new drugs not previously registered in Pakistan, including registration certificates from other countries and any other relevant details needed for review.
Originalbeschreibung:
Originaltitel
Application Form for Registration of a Drug for Local Manufacture
This document is an application form for registering a new drug for local manufacture and sale in Pakistan. It requests information about the drug such as its name, manufacturer, composition, dosage, clinical use, side effects, stability studies, packaging, and pricing. The applicant is required to provide details on the drug's manufacture and quality control processes as well as proposed labeling. Additional information must be submitted for new drugs not previously registered in Pakistan, including registration certificates from other countries and any other relevant details needed for review.
Copyright:
Attribution Non-Commercial (BY-NC)
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This document is an application form for registering a new drug for local manufacture and sale in Pakistan. It requests information about the drug such as its name, manufacturer, composition, dosage, clinical use, side effects, stability studies, packaging, and pricing. The applicant is required to provide details on the drug's manufacture and quality control processes as well as proposed labeling. Additional information must be submitted for new drugs not previously registered in Pakistan, including registration certificates from other countries and any other relevant details needed for review.
Copyright:
Attribution Non-Commercial (BY-NC)
Verfügbare Formate
Als DOC, PDF, TXT herunterladen oder online auf Scribd lesen
APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE
I/we.........................of ................hereby apply for registration of the drug
namely ..................details of which are enclosed. Date ....................... Place ...................... ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG 1. Name and address of the manufacturer • 2, Name of drug • (a) Generic/international non-proprietary name: (b) Proprietory name, if any: 3 Name under which drug is proposed to be sold 4. Dosage from of the drug: 5. Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation : 6. Proposed dosage : (a) for adults. (b) children by age group. (c) infant (d) special groups.
7. Main Pharmacological group to which the drug belongs:
8. Pharmacological and clinical data : (a) recommended clinical use and the claims to be made for the drug. (b) contra-indications. (c) toxicity or the side-effects. (d) any directions for the use to be included in the labelling, warning and precautions in use : symptoms of over dosage should be given alongwith the treatment including antidotes, where required. 9. Proposed route of administration. 10. Description of the method of manufacture and quality control with details of the equipment. 11. Specifications, with details of analytical procedure for each ingredient and the finished drugs (not required in case of a drug for which pharmacopocial standards recognised under the Drugs Act, 1976, are claimed). 12. Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). 13. Stability Summary : (a) A complete description of and date derived from studies on the stability of new drug, including information pertaining to the suitability of the analytical methods used (b) Shelf-life when stored under expected or directed storage conditions. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. (Such observations should be utilized for appropriate labelled storage conditions or warning statements). (e) Type of container/package, with the nature of material, package testing (chemical, mechanical, environmental). 14. Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain from counterfeiting shall also be submitted. 15. Pack size (s) and proposed maximum retail price with the following details:- (i) Cost per retail pack of each active and non-active. Ingredients : (ii) Cost of each packing material. (iii) Cost of direct labour, 16. Justification : (Only in case of a new entity). 17. Patent number, if any, with date and its date of expiry. 18. In case of a new drug (entity) not yet registered in Pakistan : (i) enclose certificate of registration and Free Sale from any of the following countries: Japan, USA and European Company Member countries. (ii) Any other relevant information that may be required by the Board for consideration of this application.